Home / 510(k) Clearances / K040085

510(k) K040085

PERSONAL WARMING LUBRICANT by Qualis, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2004
Date Received
January 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

Other clearances by Qualis, Inc.

  • K050211 — PERSONAL WARMING GEL (March 17, 2005)
  • K050212 — PERSONAL WARMING JELLY (March 17, 2005)
  • K041129 — PERSONAL LUBRICATING GEL (September 24, 2004)
  • K973780 — PERSONAL LUBRICATING LIQUID (November 26, 1997)
  • K973557 — LUBRIGLIDE (October 10, 1997)

Other clearances for product code HIS

  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)
  • K222068 — Durex Penck III Regular (October 12, 2022)